Continuous Monitoring of Body Temperature in Mothers and Their Preterm Neonates
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMedical University of Graz
About this trial
Preterm babies are at increased risk of becoming too cold or too warm immediately after birth because they have an immature ability to regulate their body temperature. Maintaining a normal body temperature during the first minutes after birth is important because both low and high body temperatures are associated with an increased risk of complications. Current temperature monitoring is performed intermittently using conventional thermometers and does not provide continuous information about changes in body temperature.
This prospective observational pilot study aims to evaluate the feasibility of using the SteadyTemp® adhesive thermometer, a wireless, non-invasive temperature sensor, for continuous body temperature monitoring in preterm neonates (32+0 to 36+6 weeks of gestation) during the first 15 minutes after birth. The study will also compare temperatures recorded by the adhesive thermometer with a routine rectal temperature measurement and assess skin tolerability after removal of the adhesive patch. In addition, maternal body temperature will be continuously monitored during delivery to explore the relationship between maternal intrapartum temperature and neonatal temperature during the immediate postnatal transition.
The study hypothesizes that continuous temperature monitoring with the SteadyTemp® adhesive thermometer is feasible in preterm neonates, that the recorded temperatures agree with standard rectal temperature measurements, that the device is well tolerated without clinically relevant skin irritation, and that maternal intrapartum temperature correlates with neonatal body temperature during the immediate postnatal transition. The results of this pilot study will provide preliminary evidence to support future studies evaluating continuous, non-invasive temperature monitoring as a tool to improve thermal management of preterm neonates immediately after birth.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Preterm neonates born between 32+0 and 36+6 weeks of gestation.
Written informed consent obtained from the mother (or legally authorized representative, where applicable according to national legislation) before delivery and before any study-specific procedures are performed.
Disqualifiers
Gestational age <32+0 weeks or ≥37+0 weeks.
No decision to conduct full life support.
Written informed consent not obtained before delivery.
Congenital malformation.
Trial population
The study population consists of preterm neonates born between 32+0 and 36+6 weeks of gestation and their mothers at the Department of Obstetrics and Gynaecology of the Medical University of Graz, Austria, and the University Hospital Essen, Germany. Eligible mother-preterm neonate pairs will be recruited before delivery after written informed consent has been obtained. Neonates will undergo routine postnatal care, with additional continuous temperature monitoring using the investigational device during the immediate postnatal transition.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Temperature monitoring
DeviceSteadyTemp® (SteadySense GmbH, Graz, Austria) is a wireless, non-invasive adhesive thermometer designed for continuous body temperature monitoring. In this study, one adhesive thermometer will be applied to the mother's skin at least 10 minutes before delivery for continuous intrapartum temperature monitoring, and a second thermometer will be applied to the preterm neonate's right axillary region immediately after birth for continuous temperature monitoring during the first 15 minutes of postnatal transition. Temperature data are recorded continuously and transferred via near-field communication (NFC). The device is used in addition to standard clinical care and does not replace routine rectal temperature measurement, which serves as the clinical reference standard.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Mother-Preterm Neonate Pairs1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of continuous body temperature monitoring using the SteadyTemp® adhesive thermometer in preterm neonates
Feasibility will be assessed as the proportion of preterm neonates with successful placement of the SteadyTemp® adhesive thermometer and uninterrupted continuous body temperature recording during the first 15 minutes after birth.
Time frame
15 minutesSecondary outcomes
1
Agreement between SteadyTemp® and rectal body temperature measurements
Agreement between the temperature recorded by the SteadyTemp® adhesive thermometer and the single routine rectal temperature measurement will be assessed using Bland-Altman analysis and correlation analysis.
Time frame
15 minutes after birth (at the time of routine rectal temperature measurement).2
Neonatal skin tolerability after application of the SteadyTemp® adhesive thermometer
Neonatal skin tolerability after application of the SteadyTemp® adhesive thermometer
Time frame
Immediately after removal of the adhesive thermometer (15 minutes after birth).3
Association between maternal intrapartum temperature and neonatal body temperature during immediate postnatal transition
Correlation between continuously measured maternal intrapartum temperature and neonatal body temperature during the first 15 minutes after birth.
Time frame
From approximately 10 minutes before birth until 15 minutes after birth.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of Graz
Lead sponsor
Universität Duisburg-Essen
Collaborator
Source ClinicalTrials.gov